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Seawater saline solution

EUDAMED

Class IIa (EU MDR)

Ref TYPE D18-125mL-SprayModel Type D1/D2/D3/D4/D5/D6/D7/D8/D9/D10/D11/D12/D13/D14/D15/D16/D17/D18/D19

by Zhuhai Ninuo Biological Technology Co., Ltd.

Identity

Trade Name
Seawater saline solution EUDAMED
Device Name
Seawater Saline Solution (Isotonic) EUDAMED
Model / Reference
Type D1/D2/D3/D4/D5/D6/D7/D8/D9/D10/D11/D12/D13/D14/D15/D16/D17/D18/D19 EUDAMED
TYPE D18-125mL-Spray EUDAMED

Identifiers

Primary DI / UDI-DI
06970082862015 EUDAMED
Basic UDI-DI
697008286H162CY EUDAMED
Direct Marketing DI
06970082862015 EUDAMED
EMDN Code
Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Seawater saline solution by Zhuhai Ninuo Biological Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000023308
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

  • EUDAMED 9a676c50-4dfd-419c-be0c-3395efd62c99 61 fields · synced Jun 19, 2026